Lawsuits

A former farm worker named Enrique Rubio may just be the right “David” to take down “Goliath” chemical company Monsanto. Rubio filed suit against the manufacturer of Roundup® early last week, claiming that the company’s infamous herbicide is the cause of his bone cancer and inability to work.

Roundup’s® safety has been hotly debated for years among scientists, environmental activists and those concerned with human health. Rubio’s suit, if successful, may put an end to that debate once and for all by forcing Monsanto to provide proof that it knowingly withheld data on the true dangers of its flagship product.

The active ingredient in Roundup®, a nasty chemical called glyphosate, was discovered in 1970. Rubio’s suit states that [g”]lyphosate is a broad-spectrum, non-selective herbicide used in a wide variety of herbicidal products around the world. Plants treated with glyphosate translocate the systemic herbicide to their roots, shoot regions and fruit, where it interferes with the plant’s ability to form aromatic amino acids necessary for protein synthesis. Treated plants generally die within two to three days. Because plants absorb glyphosate, it cannot be completely removed by washing or peeling produce or by milling, baking, or brewing grains.”

Monsanto claimed glyphosate was “a technological breakthrough: it could kill almost every weed without causing harm either to people or to the environment.” However, that doesn’t seem to be the case. The World Health Organization (WHO) asserts that glyphosate is “a probable cause of cancer.”

Why would Monsanto take such a big risk? Money. The company needed a win in the industry in order to continue its “reputation and dominance in the marketplace. Largely due to the success of Roundup® sales, Monsanto’s agriculture division was out-performing its chemicals division’s operating income, and that gap increased yearly.” So, rather than go with a less toxic product, Monsanto sold humanity and the planet for its own bottom line.

Wait, a less toxic product? Is that possible? Indeed, it is possible and was possible from Day One. “The harm caused by [Monsanto’s] Roundup® products far outweighed their benefit. …Roundup® products were and are more dangerous than alternative products and {the company] could have designed its Roundup® products to make them less dangerous. Indeed, at the time that [Monsanto] designed its Roundup® products, the stat of the industry’s scientific knowledge was such that a less risky design or formulation was attainable.”

So basically, Monsanto decided it was better (for it) to release a carcinogenic product that it was to spend a bit more money taking the time to research a less harmful alternative. The sad thing is, knowing that its product was dangerous, Monsanto had to pull some serious strings to get it approved.

The EPA originally classified glyphosate as “possibly carcinogenic to humans” in 1985. However, “after pressure from Monsanto, including contrary studies it provided to the EPA, the EPA changed its classification to evidence of non-carcinogenicity in humans in 1991.”

The “contrary studies” involved two “independent” labs that willfully committed scientific fraud. The FDA inspected one lab, Industrial Bio-Test Laboratories (IBT), in 1976. That inspection uncovered “discrepancies between the raw data and the final report relating to the toxicological impacts of glyphosate.”

This prompted the EPA to do its own audit. The EPA found the same results. Moreover, one EPA reviewer said that, “after finding ‘routine falsification of data’ at IBT, that it was ‘hard to believe the scientific integrity of the studies when they said they took specimens of the uterus from male rabbits.’” Unsurprisingly, three of IBT’s top executives were convicted of fraud in 1983.

The other lab, Craven Laboratories, was hired by Monsanto to perform additional tests on glyphosate in 1991. “In that same year, the owner of Craven Laboratories and three of its employees were indicted, and later convicted, of fraudulent laboratory practices in the testing of pesticides and herbicides.”

According to Rubio’s complaint, “Despite the falsity of the tests that underlie its registration, within a few years of its launch, Monsanto was marketing Roundup® in 115 countries.” Nowadays, Monsanto’s glyphosate products can be found in 130 countries and are approved for use on over 100 different crops. If you think that you’re safe, think again.

“[Glyphosate products] are ubiquitous in the environment. Numerous studies confirm that glyphosate is found in rivers, streams, and groundwater in agricultural areas where Roundup® is used. It has been found in food, in the urine of agricultural workers, and even in the urine of urban dwellers who are not in direct contact with glyphosate.”

The New York Attorney General sued Monsanto in 1996 claiming its Roundup® advertising was “false and misleading.” The suit specifically challenged “Monsanto’s general representations that its spray-on glyphosate-based herbicides, including Roundup®, were ‘safer than table salt’ and ‘practically non-toxic’ to mammals, birds, and fish.”

Monsanto agreed, in 1996, to “cease and desist from publishing or broadcasting any advertisements [in New York].”

Various other governments have either severely restricted or outright banned the sale of Roundup®, including the Netherlands, Brazil, France, Bermuda, Sri Lanka and Columbia.

Indeed, this may be the beginning of the end for Monsanto and Roundup®. One can only hope that justice will prevail in Rubio’s case and the chemical giant will be forced to tell the truth and face the consequences.

The defendant companies are USPLabs, LLC (“USPLabs”) and General Nutrition Center Holdings Inc. (“GNC”). USPLabs sells a variety of energy and weight loss dietary supplements under the brand name of OxyElite Pro through GNC.

The complaint was filed in the U.S. District Court for the District of New Jersey. In it, Plaintiff Barot says he bought and used OxyElite Pro supplements while living in New Jersey between March 2010 and October 2011. He says he bought the product at a GNC store. Barot says OxyElite Pro was sold in New Jersey between January 2008 and November 2013.

In April 2012, the Food and Drug Administration warned USPLabs about the use of a dangerous stimulant called dimethylamylamine (“DMMA”) in its products. A class-action complaint followed and was resolved by a settlement agreement. Hogan v. USPLabs LLC, No. BC486925 (Cal. Super. Ct., L.A. County).

However, during and subsequent to Hogan v. USPLabs, LLC, Defendant USPLabs contained and or included another dangerous ingredient in OxyElite Pro called, Aegeline. Public health officials are currently investigating severe illnesses allegedly connected to Aegeline, including liver disease and hepatitis.

Plaintiff Barot points to medical records submitted to the FDA by the Hawaii Department of Health in which patients who used OxyElite Pro became severely ill. The complaint states that the use of the product was the only common factor among the patients and many became well again after stopping its use. Therefore, the complaint argues, the likelihood that OxyElite Pro caused the illnesses is strong.

While some consumers were lucky enough to get well after they ceased ingesting the dietary supplement, for others, the damage had already been done. Several patients sustained liver injuries that required transplantation. Tragically, one patient died before a transplant could be performed. As of February, OxyElite Pro has been linked to 97 cases of hepatitis.

On Oct. 11, 2013, the FDA issued a warning to USPLabs to stop distribution of all products containing aegeline. The company conducted a voluntary recall about one month later, but Barot says it failed to provide any notice to consumers.

Specifically, Barot says he and other potential class members suffered economic damage in buying USPLabs’ products, which they would not have taken had they known of aegeline’s potential adverse effects. He also alleges that inadequate labeling on the product constituted an unfair trade practice because the ingredients were unfit for safe use and that the defendant companies were unjustly enriched at the expense of consumers’ health.

As lawsuits concerning the testosterone therapy drug AndroGel have recently been filed, a great deal of information has come to light concerning the marketing of that product.

Here is an excerpt from one of the current AndroGel lawsuits:

“In 2000, when the FDA approved AndroGel, the company announced that the market was ‘four to five million American men.’ By 2003, the number increased to ‘up to 20 million men.’ However, a study published in the Journal of the American Medical Association (‘JAMA’) in August 2013 entitled ‘Trends in Androgen Prescribing in the United States, 2001-2011’ indicated that many men who get testosterone prescriptions have no evidence of hypogonadism. For example, one third of men prescribed testosterone had a diagnosis of fatigue, and one quarter of men did not even have their testosterone levels tested before they received a testosterone prescription.”

Does it really seem likely that the prevalence of hypogonadism would quadruple in three years, or does this simply look like a case of improper marketing? It is interesting to note that when then-manufacturer of AndroGel, Unimed Pharmaceuticals, Inc., first sought AndroGel approval by the FDA in 1999, “hypogonadism was estimated to affect approximately ‘one million American men.’” A twenty-fold increase in disease prevalence is staggering, and would represent an epidemic if it were real. Thankfully, it isn’t.

However, the good news that hypogonadism isn’t so prevalent may likely be eclipsed by the prevalence of AndroGel use and the accompanying negative side effects — which include a dramatically-increased risk for heart attack and stroke.

WARNING: Research shows AndroGel (AbbVie, Inc., Abbott Laboratories, Inc.) is overprescribed and can lead to “serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.”

AndroGel is a topically-applied gel containing testosterone at concentrations of either 1% or 1.62% used by patients suffering from hypogonadism, or “low-testosterone”. While this condition does persist in American society today, “Low-T” isn’t nearly as prevalent as the aforementioned companies have led many to believe through what has become an award-winning marketing campaign.

As of February 7th 2014, the United States District Court for the Northern Division of Illinois (Eastern Division) began handling a lawsuit against the manufacturers of AndroGel, in which it is alleged that these companies “participated in, authorized, and directed the production and promotion of [AndroGel] when they knew, or with the exercise of reasonable care should have known, of the hazards and dangerous propensities of [AndroGel] and thereby actively participated in the tortious conduct which resulted in the injuries suffered by [our client].”

It is also noted that the client mentioned above could not have come to know the dangers posed by AndroGel sooner due to the fact that AbbVie and Abbott Laboratories “misrepresented and continue to misrepresent to the public and to the medical profession that the drug AndroGel is safe and free from serious side effects,” stating that these companies “have fraudulently concealed facts and information that could have led [our client] to discover a potential cause of [the side effects experienced].”

This is one of three similar such lawsuits filed that day, all raising the same concerns regarding AndroGel safety and marketing. To elucidate those concerns, this lawsuit cites several scientific studies. First, the team cites a 2010 New England Journal of Medicine Study titled “Adverse Events Associated with Testosterone Administration” that was stopped because too many men experienced negative side effects. Next, the team cites a 2013 Journal of the American Medical Association study titled “Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels,” “which indicated that testosterone therapy raised the risk of death, heart attack and stroke by about 30%.”

Another study released January 29th of this year was cited, titled “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men” determining testosterone therapy doubled the risk for heart attack in men over 65 and younger than 65 who had a history of heart disease.

Though AndroGel commercials describe some of the possible negative side effects of the product, particularly those that can follow by secondary contact (handling the clothes of a person who had applied AndroGel), the risk for heart attack and stroke is absent from their warnings.

As more information becomes available regarding AndroGel lawsuits and the danger of AndroGel, we will be sure to pass the knowledge on to you. If you or a loved one used AndroGel, you too may be eligible for significant financial compensation as this AndroGel lawsuit proceeds. For more information, or a free, no-obligation case consultation, contact our team of AndroGel lawyers at the information provided below. We have the compassion, experience, and resources to win the justice you deserve. Call today and see how we can help.

On October 26th, a federal court in California allowed a lawsuit against Google Inc. to proceed in which it is alleged that Google has violated privacy laws by scanning the emails of persons who do not use Google’s email service, Gmail, for the purpose of advertisement optimization.

While it is currently legal for Google and other email service providers to scan the emails of their users in effort to advertise more effectively, it seems that Judge Lucy Koh of the Northern District Court of California is suspect of the legality of a company tapping emails of those to whom it does not provide service, and who have not agreed to the relevant Terms of Service.

According to The Washington Post “Google says that the automated scanning of all e-mails that come through its servers — used to work its spam filter but also to build user profiles and target advertisements — is vital to running its e-mail service. [ ] But Koh rejected that argument, saying Google’s privacy policy does not mention that the site collects the content of e-mails, either between Gmail users or between Gmail users and non-Gmail users.”

This is not the only such lawsuit faced by our nation’s “best company to work for” (2013); in another case it is alleged that the web giant has infringed on the privacy of Americans in the photographing of millions of US addresses for the Street View function of Google Maps. As was reported by the New York Times, because hundreds of millions of people use Google’s services around the world, “if it is, as expected, certified as a class action, the fines could be enormous.”

As of November 4th, Johnson & Johnson agreed to a $2.2 billion deal in the settlement of pending criminal and civil charges that “alleged the healthcare giant illegally marketed its Risperal antipsychotic [along with Invega and Natrecor], and also paid kickbacks to physicians and Omnicare, the largest nursing home/pharmacy [company in the US,] to boost prescriptions.” (pharmalive.com)

There are essentially two issues at play here. First, Johnson & Johnson encouraged off-label use of several drugs. This in itself is illegal, as the uses of drugs must be approved by the FDA. Next is the issue of kickbacks – illegal greasing of pharmacies and physicians to sell more medications. J&J’s Risperal is approved by the FDA as an antipsychotic in the treatment of ailments like schizophrenia, but now it is revealed that the company paid doctors and Omnicare to prescribe the drug for the treatment of “anxiety, agitation, depression, hostility and confusion,” in elderly patients and young adults.

The US Department of Justice stated Monday that “In addition to imposing substantial monetary sanctions, the resolution will subject J&J to stringent requirements under a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). This agreement is designed to increase accountability and transparency and prevent future fraud and abuse.”

DOJ continues: “‘J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,’ said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger. ‘This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.’”

According to the New York Times, though the company “did not admit to any wrongdoing,” it has pled guilty to the illegal marketing of its products. Let’s not analyze what it means if an entity pleads guilty to a crime and maintains that it did nothing wrong — does Johnson & Johnson believe illegal marketing of strong antipsychotics to children is morally acceptable?

David Ingram and Ros Krasny of Reuters reported Monday that other pharmaceutical giants have made similar settlements in recent years: “Pfizer Inc in 2010 agreed to pay $2.3 billion to settle allegations it improperly marketed 13 drugs, including kickbacks to healthcare providers.

Last year, Britain’s GlaxoSmithKline Plc agreed to pay $3 billion to resolve criminal charges that it improperly targeted its Paxil depression treatment to children, sold its Wellbutrin antidepressant for unapproved uses and failed to inform U.S. regulators of safety risks seen with its Avandia diabetes drug.”

NY Times – In Oklahoma, a lawsuit surrounding a fatal car accident that injured an 82 year old woman and left a 70 year old woman named Barbara Schwarz dead, was settled on Friday between Toyota and the families of the two women involved. For the first time ever, a jury found Toyota responsible for sudden acceleration of their vehicle that caused the crash. Since Toyota could not show evidence that something other than a defect in the car caused the accident, the jury concluded that Toyota was responsible. More than 11 million Toyota and Lexus vehicles have had problems such as floor mats causing the accelerator to become stuck, and these vehicles have all been recalled. These millions of recalls were not great for the reputation of Toyota but despite the public embarrassment, Toyota reported its best earnings in the past five years. There have been several lawsuits against Toyota recently. In 2009 and 2010, $1.6 billion was given to Toyota vehicle owners who lost money from unintended acceleration.

Toyota claims it will not end its aggressive defense on all lawsuits against the company, especially the most recent incident involving the death of Barbara Schwarz. Both sides of the suit are happy a mutually acceptable agreement was made and Toyota is hoping this will help their image of selling their customers safe vehicles.

Some legal experts state that recent verdicts against Toyota could give way to new cases going against the car company that can cost the company billions of dollars in recalls and lawsuits. Each family of the two women from Oklahoma received $1.5 million in damages. In this case, it was found that Toyota’s actions were reckless and their electronic throttle control system was flawed.

Toyota was recently cleared in a case involving a 66 year old woman who died when crashing her 2006 Camry, in which the jury decided that the blame should fall on the driver who hit the 66 year old woman and sent her car down the wrong way on a one way street. The lawyer representing the family of the dead 66 year old women claims Toyota was responsible because they didn’t provide a brake override system.

While Toyota has avoided penalty for some of the accidents caused by defects in their cars, at least some of the victims of these accidents have won compensation. Hopefully, Toyota takes the high road and fixes the problems with its vehicles’ acceleration so no one else gets hurt.

Officials with Health Plan of Nevada knew in the late 1990s about Desai’s poor reputation after a doctor who was employed at one facility informed the company that Desai was cutting corners and compromising patient safety, Eglet said.

I’m actually much more open-minded about this defendant’s culpability. If what the article says is true – the insurer had actual knowledge that the Dr. was a menace – it does raise serious questions as to why the insurer kept the doc on the approved list. It will be interesting to see how the trial ends.

On September 9th of 2011, an Actos bladder cancer lawsuit was filed by an Actos lawyer in the United States District Court for the Eastern District of Louisiana. The lawsuit was filed on behalf of a Louisiana husband and wife. The husband developed bladder cancer after using Actos for a number of years. The Actos lawsuit discusses some of the history of Actos and its link to bladder cancer:

On April 20, 2006, Takeda Limited announced the conclusion of its collaboration
in the United States between Takeda North America and Lilly to promote and market Actos, a partnership Takeda Limited described as “a great success” and “mutually beneficial to both companies.”

The fact that Eli Lilly helped with the development, promotion, and marketing of Actos means that they can also be held liable in an Actos lawsuit.

Actos is sold as a single ingredient product under the brand name Actos, and it is also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and in combination with glimepiride (Duetact).

Most Actos lawyers (including me) will accept cases from individuals who were taking Actos or any of the drugs listed above.

Prior to Actos being approved by the FDA, a two-year carcinogenicity study was conducted on male and female rats. Drug-induced tumors were observed in male rats receiving doses of Actos that produced blood drug levels equivalent to those resulting from a clinical dose.

This is one of several pieces of evidence that indicates men are at a higher risk of developing bladder cancer while taking Actos than women are.

The PROactive study was looking at cardiovascular events and outcomes. However, the study demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators. This information was not included in the published Dormandy paper.

One issue that I’m sure will come up in any Actos lawsuit that goes to trial is the reason why this information was excluded from the Dormandy paper. Whenever negative information about a drug is concealed, juries tend to get angry.

A three-year liver safety study was also performed, and according to the FDA, that study also demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators.

On September 17, 2010, the FDA issued a Safety Announcement stating it was undertaking a review of the data from an ongoing, ten-year epidemiological study being conducted by Kaiser Permanente to evaluate the association between Actos and bladder cancer. The planned five-year interim analysis demonstrated that the risk of bladder cancer increases with increasing dose and duration of Actos use, reaching statistical significance after 24 months.

Despite this finding by the FDA, Robert Spanheimer, Vice President of Medical and Scientific Affairs for Takeda, claimed to Reuters that the Kaiser Permanente study has not shown a risk to patients of bladder cancer or other cancers from Actos.

No surprise that a VP for the manufacturer of Takeda denied that there is a risk of developing bladder cancer from taking Actos. At least one Actos lawyer will attempt to take this man’s deposition to ask him more about the risks of Actos and bladder cancer.

In early 2011, the American Diabetes Association published Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting, Piccinni, et al. Diabetes Care, 34:1369-1371 (June 2011), published ahead of print April 22, 2011. This study looked at adverse events reports made to the FDA between 2004 and 2009. The conclusion of that study was that “[i]n agreement with preclinical and clinical studies, AERS analysis is consistent with an association between pioglitazone and bladder cancer. This issue needs constant epidemiologic surveillance and urgent definition by more specific studies.”

By June of 2011, the evidence was mounting against Actos. By that time there had been several credible studies of different types that all concluded there is a link between Actos and bladder cancer.

On June 9, 2011, the European Medicines Agency (“EMA”) announced that it had been informed by the French Medicines Agency (“Afssaps”) of its decision to suspend the use of pioglitazone-containing medicines (Actos, Competact) in France while awaiting the outcome of the ongoing European review.

France’s decision was based upon a retrospective cohort study in France using the French National Health Insurance Plan which demonstrated a statistically significant increase in the risk for bladder cancer in males exposed to Actos for more than a year. The French cohort included 1.5 million patients with diabetes that were followed for 4 years (2006-2009).

On June 10, 2011, Reuters published that Germany had joined France in suspending the use of Actos after Germany’s Federal Institute for Drugs and Medical Devices (“BfArM”) reviewed the results of the French study. BfArM recommended that doctors should not put new patients on pioglitazone.

It is always bad news for a drug company when one or more countries bans or suspends the sale of a drug. I’m skeptical that Actos will be taken off the market here in the U.S., but that has more to do with my cynicism about the FDA than my opinion of the drug’s safety. The FDA looks at drug companies as its customers, not patients. The agency receives a substantial percentage of its funding from drug companies in the form of “user fees” and I think that causes the agency to be too cozy with manufacturers.

On June 15, 2011, the FDA issued another Safety Announcement stating that “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” The FDA ordered information about this risk to be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines.

The FDA reported that the risk of bladder cancer increased with increasing dose and duration of pioglitazone use. When compared to persons never exposed to pioglitazone, exposed to pioglitazone therapy for longer than 12 months was associated with a 40% increase in risk. Based on this data, the FDA calculated that therapy with Actos for longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to those who never used pioglitazone.

June 15th is an important day because it will probably trigger the statute of limitations for Actos lawsuits. What that means is that people who took Actos and got diagnosed with bladder cancer on or before June 15th of 2011 will lose their ability to file a lawsuit on June 15th of another year. Whether that year is 2012, 2013, or another year depends upon the law of the state the person resides in. If you’d like to know how long you have to file an Actos lawsuit, give me a call or e-mail me and I’ll be glad to discuss your situation with you.

The vast majority of pharmaceutical lawsuits are brought under what’s called a failure to warn theory of liability. Failure-to-warn lawsuits allege that a manufacturer of a drug didn’t accurately inform a plaintiff about the risks associated with taking a specific drug. If the manufacturer does give an adequate warning about the risks of a drug, you basically can’t sue the manufacturer if you’re hurt.

The way in which manufacturers warn the public is through the drug’s label. The label includes the very lengthy package insert that describes the risks of the drug. The pharmaceutical companies write that label in cooperation with the FDA. In other words, they don’t get to just put whatever they want there. Whatever they put in the label has to be supported by evidence and approved by the FDA.

So, the solution is simple: pharmaceutical companies could fully disclose all of the known risks of taking a drug on the drug’s label. If they did that, there wouldn’t be anymore failure to warn litigation. Case in point: Ortho-Evra. If someone uses the patch today and suffers from a pulmonary embolism tomorrow, no lawyer will take the case because the label FINALLY has a strong warning about the risks of a pulmonary embolism.

So why don’t the pharmaceutical companies disclose all the risks of a drug in the first version of a label? Because stronger warnings lead to lower sales. In other words, the drug companies would rather sell more drugs and get sued than sell less drugs and not get sued. So clearly it must be more profitable not to warn consumers and to get sued than it would be to virtually eliminate all lawsuits.

There’s even a safety valve built into the system that prevents a pharmaceutical company from writing a ridiculously overbroad warning label: The FDA. As I mentioned, there must be evidence to support everything in a label. Any warnings that aren’t justified will be rejected by the FDA. And if by some chance, the FDA rejects a warning that it shouldn’t have, the pharmaceutical company is still safe: It’s tough to win a failure to warn lawsuit if the warning was specifically rejected by the FDA.

The pharmaceutical companies therefore have it within their power to get rid of nearly all tort lawsuits against them. But they choose not to. I believe that they choose not to because it is more profitable to sell additional drugs and use the profits to pay the people who are injured and do sue.

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.